Treatment of Mycobacterium fortuitum pulmonary infection with “transfer factor” (TF): New methodology for evaluating TF potency and predicting clinical response

Abstract

The successful clinical use of dialyzable leukocyte extracts (DLE) containing transfer factor (TF) has been hampered in the past by the lack of an in vitro assay for TF activity. We have shown previously that the leukocyte migration inhibition (LMI) assay can be used to detect and quantitate TF in DLE in vitro. The development of an in vitro assay for TF has in turn permitted the development of a new method for determining the TF potency in different preparations of DLE. We report herein the first application of the LMI assay to the clinical use of DLE. As an example we present a case study in which DLE was successfully employed to treat a patient with pulmonary disease associated with an “antigen-selective” defect in cell-mediated immunity to Mycobacterium fortuitum. The clinical applications of the LMI assay illustrated in this report include: (1) documentation of the antigen-selective defect in cell-mediated immunity; (2) selection of donors for the preparation of DLE for immunotherapy; (3) determination of the TF potency of different DLE preparations; (4) prediction of the patient's in vivo response to DLE therapy; (5) determining dosages of DLE for immunotherapy and immunoprophylaxis; and (6) monitoring the patient's response to treatment with DLE.